BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENEXPERT DX SYSTEM

    Reg #: 3007867838 · FEI: 1000161215 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sanmina
    Registration Number
    3007867838
    FEI Number
    1000161215
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2700 N 1st St
    City
    SAN JOSE
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212213

    Owner / Operator

    Firm Name
    Sanmina Corporation
    Operator Number
    2129538
    Address
    13000 S. Memorial Pkwy, --
    City
    Huntsville
    State
    AL
    Postal Code
    35803
    Country
    US

    Products

    Device Name Product Code
    Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System PQA
    Instrumentation For Clinical Multiplex Test Systems NSU

    Proprietary Names

    GENEXPERT DX SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)